Can patients drop monthly injections after targeted radiotherapy for neuroendocrine tumors?
NCT ID NCT06345079
First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
Neuroendocrine tumors often keep growing despite treatment with somatostatin analogues, drugs that slow tumor growth and reduce hormone production. When that happens, doctors add peptide receptor radionuclide therapy (PRRT), a targeted radiotherapy, but they do not know whether continuing the analogue drugs afterward helps. This trial randomly assigns adults with midgut, hindgut, or pancreatic neuroendocrine tumors to either stop or continue somatostatin analogues after starting PRRT. Researchers track how long participants live without their cancer worsening and whether stopping the drugs is feasible for a larger study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- somatostatin analogues, a hormone-blocking drug used to slow neuroendocrine tumor growth
- What this could lead to
- If stopping works as well as continuing, people with neuroendocrine tumors could avoid ongoing injections and their side effects after radiotherapy. It could also set up a larger trial to confirm the approach.
- What could go wrong
- This is a small Phase 2 trial, so it can only estimate whether stopping is safe and effective, not prove it. Some participants who stop may have their tumors grow faster or develop symptoms from hormone flare, which is why the study allows short-acting octreotide for symptom control.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 78 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults over 18 years of age with well or moderately differentiated mid or hindgut neuroendocrine tumour, or pancreatic neuroendocrine tumour, metastatic and inoperable, demonstrating progression despite SSA treatment of sufficient disease magnitude to warrant PRRT as determined by the treating clinician and/or the NET Multidisciplinary Team (MDT). * Must have measurable disease on triphasic CT/MRI as per RECIST 1.1. * Ki67 ≤ 20% AND mitotic count 20 per HPF (i.e., WHO grade 1 or 2) * Patient has been receiving growth-controlling doses of SSA for at least 12 weeks prior to study entry. This is a minimum of 30 mg Octreotide or120mg lanreotide monthly. * Uptake on SSTR PET scan demonstrating somatostatin receptor expression that is suitable for PRRT as judged by the clinical team. FDG PET scans are to be done at the judgement of the treating team and are not required for enrolment into this study. * PRRT is deemed the most appropriate next treatment step (i.e., patient is inoperable, and liver directed therapies are not preferred) * ECOG performance status 0 -2 * Written informed consent. Patients must be willing to either cease or continue SSA, depending on which study arm they are randomised to. Patients must be willing to comply with all other study requirements * Adequate renal, hepatic and haematologic function as judged by the treating team * Life expectancy of at least 12 months * Availability of tissue from resection or biopsy samples is desired but is not mandatory for study inclusion. Tissues will only be retrieved if the patient consents to optional translational research sample collection. Similarly, bloods for research purposes will only be collected from those patients who consent to optional translational research sample collection. * Non-functioning NET: SSA treatment will have been commenced for control of tumour growth and not for carcinoid or other hormone overproduction syndrome, as judged by the clinician and/or NET MDT. Non-functioning NET is judged by the treating clinical team based on patient symptomatology. In addition, for this study, non-functioning tumour is defined as: * 24-hour urine 5-hydroxyindoleacetic acid (5HIAA) of \<1.5x upper limit of normal (applies to mid and hind gut patients only). * Please note: routine measurement of gastrin, insulin, C-peptide levels, glucagon etc. is not required unless clinically indicated. * Never had escalation of the SSA treatment dose to control carcinoid carcinoid or other hormone-related symptoms * Never required short acting SSA treatment to control carcinoid carcinoid or other hormone-related symptoms * No significant carcinoid induced valvular heart disease IE: Echocardiogram to be done in all patients within 26 weeks of study enrolment and deemed safe to proceed with PRRT by the treating team. Exclusion Criteria: * This study is for pancreatic, mid-gut and hind-gut NET only. Gastric and lung NETs are excluded * Any patient on an SSA dose lower than the standard growth-control dose. Patients must have been on octreotide 30 mg or lanreotide 120 mg for at least 3 months prior to study entry. * Prior chemotherapy or targeted therapy (e.g., everolimus). Patients who have received prior local therapy, including external beam radiotherapy and liver directed therapy prior to or during SSA therapy are eligible. * Any contraindication to PRRT, as per local institutional practice. * Pregnancy. For female patients of childbearing potential and male patients with a female partner who is of childbearing potential, contraception and counselling is required. * Prior PRRT. Patients being considered for re-treatment with PRRT are not eligible * Uncontrolled central nervous system metastases. Patients must have completed any surgery or radiation at least 4 weeks prior to registration and must be off corticosteroids for at least 2 weeks * Any patient, in the opinion of the investigator, who will not comply with study assessments and follow up visits. These might include any social, psychological, or geographical concerns, including alcohol/drug abuse * Any poorly controlled concurrent medical illness that may prevent the patient from complying with study assessments and follow up. This is to be judged by the treating team * Any concurrent or prior malignancy that, in the opinion of the treating team, may interfere with study assessments and endpoints
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
17 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Allan Blair Cancer Centre
RECRUITINGRegina, Saskatchewan, S4T 7T1, Canada
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BC Cancer Agency, Vancouver Cancer Centre
RECRUITINGVancouver, British Columbia, V5Z 4E6, Canada
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Cairns Hospital
RECRUITINGCairns, Queensland, 4870, Australia
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Cross Cancer Institute
RECRUITINGEdmonton, Alberta, T6G 1Z2, Canada
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Fiona Stanley Hospital
RECRUITINGPerth, Western Australia, 6150, Australia
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Kalgoorlie Health Campus
RECRUITINGKalgoorlie-Boulder, Western Australia, 6430, Australia
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London Health Sciences Centre Research Institute (LHSCRI)
RECRUITINGLondon, Ontario, N6A 5W9, Canada
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Odette Cancer Centre Sunnybrook Health Sciences Centre
RECRUITINGToronto, Ontario, TG 260, Canada
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Ottawa Hospital Research Institute
RECRUITINGOttawa, Ontario, K1Y 1J8, Canada
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Peter MacCallum Cancer Centre
RECRUITINGMelbourne, Victoria, 3000, Australia
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Royal Brisbane and Womens Hospital
RECRUITINGBrisbane, Queensland, 4006, Australia
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Royal North Shore Hospital
RECRUITINGSydney, New South Wales, 2065, Australia
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Saskatoon Cancer Centre
RECRUITINGSaskatoon, Saskatchewan, S7N 4H, Canada
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The Queen Elizabeth Hospital
RECRUITINGAdelaide, South Australia, 5000, Australia
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Toowoomba Hospital
RECRUITINGToowoomba, Queensland, 4350, Australia
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University Health Network Princess Margaret Cancer Centre
RECRUITINGToronto, Ontario, M5G 2M9, Canada
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Wollongong Hospital
RECRUITINGWollongong, New South Wales, 2502, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Swiss registry aims to map rare neuroendocrine tumors
- Can a vast image library unlock better pancreatic diagnoses?
- Can a sharper PET tracer light up hidden neuroendocrine tumors?
- Can patient records reveal who will respond to neuroendocrine tumor treatments?
- Can a new drug formulation shrink Hard-to-Treat neuroendocrine tumors?
- One dose may not fit all: blood tests could tailor cancer drug dosing